The European Medicines Agency (EMA) says it is expecting to receive 97 applications for medicines marketing authorisations (MAs) in 2011, compared to the 95 it received in 2010.
These will include 40 applications for new human-use medicines, slightly up on the 38 received last year, plus 12 for new orphan drugs (14 in 2010) and 42 applications for generics (41), forecasts the EMA Management Board, which has now approved the Agency’s work programme and budget for 2011.
The approved budget for the Agency this year will total 208.9 million euros, up just 0.23% over 2010’s total, and will include fee revenue totalling 161 million euros compared to 152.8 million euros in 2010, plus a contribution from the European Union (EU) of 33.5 million euros, which is a considerable drop from last year’s contribution of 39.1 million euros. The special orphan medicines fund provided by the EU is also down significantly, from 8.2 million euros to 4.9 million euros.
The Agency is not expecting to create any new staff posts this year, adds the Board; the staff ceiling is set to be fixed at the 2010 level of 567 “temporary agents.”
The Management Board has also adopted the new EMA Road Map to 2015. “Building on the success of the first Road Map for 2005-2010, the new strategy focuses on delivery of the Agency’s core business, together with three priority areas for future actions to strengthen the Agency’s role in addressing public health needs, facilitating access to medicines and optimising safe use of medicines,” it says.
The work programme and Road Map will be published this month. Adoption of the Road Map will follow a public consultation, to be held during the first half of the year. This will take into account responses from 71 stakeholders, including EU institutions and member states, plus organisations representing patients and consumers, healthcare professionals, industry, academia and health technology assessment (HTA) bodies.
Meantime, the EMA has also signed a new working arrangement with the European Centre for Disease Prevention and Control (ECDC), with the aim of enhancing cooperation and mutual consultation between the two agencies in areas of common interest, and ensuring that they make best use of their resources while avoiding duplication of effort and overlaps in their activities.
Initiatives agreed under the new working arrangement will include: - the exchange of information on vaccines, antimicrobial resistance and antiviral medicines; - monitoring the risk/benefit balance of vaccines; - collaboration on substances of human origin, such as the use of human tissue or cells in medicines; and – participation in meetings and joint projects.